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Functional Outcomes in Ulcerative Colitis Patients With Ileal Pouch Anal Anastomosis Treated With High Intensity Focused Electromagnetic Stimulation

Functional Outcomes in Ulcerative Colitis Patients With Ileal Pouch Anal Anastomosis Treated With High Intensity Focused Electromagnetic Stimulation: A Prospective Pilot Study

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests the Emsella chair, which uses strong electromagnetic stimulation, in adults with a J pouch who leak stool. It is for people who had J pouch surgery for ulcerative colitis or IBDU (bowel inflammation whose type is unclear). Researchers will check stool leakage and health-related quality of life before, during, and after treatment.

The purpose of this research is to evaluate functional outcomes in patients with Ulcerative Colitis and IBDU who have received an ileal pouch anal anastomosis (IPAA), commonly referred to as a J pouch, after treatment with the Emsella chair. We will specifically look at fecal incontinence and patient health related quality of life outcomes before, during and after course of treatment.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Are 18 years old or older.
  • Had J pouch surgery for ulcerative colitis or IBDU. A J pouch is a pouch made from the small intestine.
  • Had J pouch surgery at least 1 year ago.
  • Have stool leakage, also called fecal incontinence.

Who can't join

  • Have medical records marked “break the glass” (restricted access) or “research opt out.”
  • Are younger than 18.
  • Do not have a J pouch, or had one made for a reason other than ulcerative colitis or IBDU.
  • Have active pouchitis, which is inflammation of the J pouch.
  • Have an active fistula, which is an abnormal tunnel between body parts.
  • Had the diagnosis changed to new Crohn’s disease after surgery.
  • Have metal or medical devices implanted in the body.
  • Are pregnant.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Individuals 18 years old or older are included. * Patients who have a J pouch reconstruction due to Ulcerative Colitis or IBDU * Must be at least 1 year out from J pouch surgery * Have fecal incontinence Exclusion Criteria: * Any records flagged "break the glass" or "research opt out." * Pediatric Patients \<18 years of age * Did not receive a J pouch * Patients who received a J pouch for any other indication, including but not limited to Crohn's disease, familial adenosis polyposis * Have active pouchitis * Have an active fistula * If reclassified to de novo Crohn's after surgery * Have implanted metal devices or medical devices * Pregnant patients

Study sites (1)

CA